HyperSoft Advanced 8510-0308

GUDID 00811425027844

V-Trak

MICROVENTION INC.

Neurovascular embolization coil

• Primary Device ID: 00811425027844
• NIH Device Record Key: 3dbcbd40-3f2d-4583-956c-b135348f0ac9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperSoft Advanced
• Version Model Number: 8510-0308
• Catalog Number: 8510-0308
• Company DUNS: 003263105
• Company Name: MICROVENTION INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811425027844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132952

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-19
• Device Publish Date: 2015-12-29

On-Brand Devices [HyperSoft Advanced]

• 00812636022543: V-Trak
• 00812636022536: V-Trak
• 00812636022529: V-Trak
• 00812636022512: V-Trak
• 00812636022505: V-Trak
• 00812636022499: V-Trak
• 00812636022482: V-Trak
• 00812636022475: V-Trak
• 00812636022468: V-Trak
• 00812636022451: V-Trak
• 00812636022444: V-Trak
• 00812636022437: V-Trak
• 00812636022420: V-Trak
• 00812636022413: V-Trak
• 00812636022406: V-Trak
• 00812636022390: V-Trak
• 00812636022383: V-Trak
• 00812636022376: V-Trak
• 00812636022369: V-Trak
• 00812636022352: V-Trak
• 00812636022345: V-Trak
• 00812636022338: V-Trak
• 00812636022321: V-Trak
• 00812636022314: V-Trak
• 00812636022307: V-Trak
• 00812636022291: V-Trak
• 00812636022284: V-Trak
• 00812636022277: V-Trak
• 00811425027912: V-Trak
• 00811425027905: V-Trak
• 00811425027899: V-Trak
• 00811425027882: V-Trak
• 00811425027875: V-Trak
• 00811425027868: V-Trak
• 00811425027851: V-Trak
• 00811425027844: V-Trak
• 00811425027837: V-Trak
• 00811425027820: V-Trak
• 00811425027813: V-Trak
• 00811425027806: V-Trak
• 00811425027790: V-Trak
• 00811425027783: V-Trak
• 00811425027776: V-Trak
• 00811425027769: V-Trak
• 00811425027752: V-Trak
• 00811425027745: V-Trak
• 00811425027738: V-Trak
• 00811425027721: V-Trak
• 00811425027714: V-Trak
• 00811425027707: V-Trak